SIO GENE THERAPIES INC. The following discussion and analysis of our financial condition, results of operations and cash flows should be read in conjunction with (i) the interim unaudited condensed consolidated financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q, and (ii) the audited consolidated financial statements and notes thereto and management's discussion and analysis of financial condition and results of operations for the fiscal year endedMarch 31, 2021 , included in our Annual Report on Form 10-K, filed with theSecurities and Exchange Commission (the "SEC") onJune 9, 2021 . This Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements are often identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "project," "will," "would" or the negative or plural of these words or similar expressions or variations, although not all forward-looking statements contain these identifying words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements appearing in a number of places throughout this Quarterly Report on Form 10-Q include, but are not limited to, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things:
•the timing and outcome of our exploration of potential strategic alternatives;
•our anticipated uses of cash, cash runway and future cash position;
•the timing, cost and anticipated savings benefits of internal restructurings that we have conducted or may conduct in the future, including headcount reductions;
•our public securities' potential liquidity and trading;
•continued service of, or changes required in, our officers or other key personnel;
•our estimates regarding our results of operations, financial condition, liquidity, capital requirements, prospects, growth and strategies;
•our lack of profitability and the need for additional capital;
•the impact of laws and government regulations;
•the effects of the COVID-19 pandemic on our business and operations; and
•our ability to operate our business and effectively explore and pursue potential strategic alternatives under evolving and uncertain macroeconomic conditions, such as high inflation and a recessionary environment;
We have based these forward-looking statements largely on our current expectations and projections about future events, including the responses we expect from the FDA and other regulatory authorities and financial trends that we believe may affect our financial condition, results of operations, business strategy, nonclinical studies and clinical trials and financial needs. Such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled "Risk Factors" set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q and in our other filings with theSEC . These risks are not exhaustive. You should not rely upon forward-looking statements as predictions of future events. Furthermore, such forward-looking statements speak only as of the date of this report. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements as predictions of future events. 17
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Overview
Until recently, we were a clinical-stage company focused on developing gene therapies to treat neurodegenerative diseases: AXO-AAV-GM1 for the treatment of GM1 gangliosidosis, AXO-AAV-GM2 for the treatment of GM2 gangliosidosis (including Tay-Sachs and Sandhoff diseases) and AXO-Lenti-PD for the treatment of Parkinson's disease. During this year, we wound down these programs and are continuing research and development efforts on one pre-clinical program. InJune 2018 , we entered into the Oxford Agreement with Oxford pursuant to which we received a worldwide, royalty-bearing, sub-licensable license under certain patents and other intellectual property controlled by Oxford to develop and commercialize AXO-Lenti-PD and related gene therapy products. InFebruary 2022 , we provided notice to Oxford to terminate the Oxford Agreement to develop and commercialize AXO-Lenti-PD and related gene therapy product candidates. We determined to terminate the Oxford Agreement and redirect resources to our AXO-AAV-GM1 and -GM2 programs, as well as other strategic initiatives, due to several factors, including the resource requirements and development timelines to reach meaningful value inflection for the program and an increasingly challenging market and regulatory environment for Parkinson's disease. We continued to incur immaterial expenses in connection with the Oxford Agreement until its termination became effective onJune 30, 2022 . InDecember 2018 , we entered into the UMMS Agreement with UMMS pursuant to which we received a worldwide, royalty-bearing, sub-licensable license under certain patent applications and any patents issuing therefrom, biological materials and know-how controlled by UMMS to develop and commercialize gene therapy product candidates, including AXO-AAV-GM1 and AXO-AAV-GM2, for the treatment of GM1 gangliosidosis and GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease). InApril 2022 , we provided notice to UMMS to terminate the UMMS Agreement, which termination became effectiveAugust 31, 2022 . These two programs have been wound down; we are negotiating final payments to certain program vendors. In parallel with our decision to terminate the AXO-AAV-GM1 and -GM2 programs, inApril 2022 , our board of directors approved and we announced the strategic decision to explore and review a range of strategic alternatives focused on maximizing stockholder value from our existing cash and cash equivalents, including a potential sale, merger, business combination or similar transaction. In connection with these actions, and as approved by our board of directors, we began implementing a significant headcount reduction, which concluded inAugust 2022 . While we continue to conduct one pre-clinical research and development program, we are devoting substantial time and resources to exploring strategic alternatives. Despite devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We have not set a timetable for completion of this strategic review process, and our board of directors has not approved a definitive course of action. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value or that we will make any additional cash distribution to our stockholders. If a strategic transaction is not completed, including if our board of directors determines that no potential transactions or counterparties would be in the best interests of our stockholders, our board of directors may decide to pursue a dissolution and liquidation. In addition, certain of our agreements could require final payments to the counterparty as a result of the recent termination of our licenses and clinical trials.
COVID-19 Business Update
We are continuing to closely monitor the impact of the global COVID-19 pandemic on our business and operations as well as measures and guidance from governmental authorities.
In the conduct of our business activities during the pandemic, we took actions
designed to protect the safety and well-being of patients, healthcare workers
and employees. For patients previously enrolled in our clinical trials, we
worked closely with clinical trial investigators and site staff to continue
treatment in compliance with trial protocols and to uphold trial integrity,
while working to observe government and institutional guidelines designed to
safeguard the health and safety of patients, clinical trial investigators and
site staff. While the COVID-19 pandemic has not resulted in a significant delay
to our prior clinical development timelines to-date and has not had a
significant impact to our historical operations, the COVID-19 pandemic continues
to evolve, including as a result of variants. The effects of the COVID-19
pandemic, together with recent macroeconomic uncertainty, could materially
impact our strategic goals to explore and review a range of strategic
alternatives focused on maximizing stockholder value from our existing cash and
cash equivalents, including a potential sale, merger, business combination or
similar transaction. The COVID-19 pandemic and related impacts (including
inflationary pressures and macroeconomic uncertainty) could result in
significant and prolonged disruption of global financial markets, which has
negatively impacted and may continue to reduce our ability to access capital,
limiting the financial resources available to us as well as to any potential
strategic counterparty.
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We do not yet know the full extent of potential impacts on our business,
operations, strategic goals, or the global economy as a whole. However, these
effects could harm our operations, and we will continue to monitor the COVID-19
situation closely. For additional information about risks and uncertainties
related to the COVID-19 pandemic that may impact our business, financial
condition and results of operations, see the section titled "Risk Factors" under
Part II, Item 1A in this Quarterly Report on Form 10-Q.
Financial Operations Overview
Revenue
We have not generated any revenue from the sale of any products, and we do not expect to generate any revenue unless and until we obtain regulatory approval of and begin to commercialize any product candidates.
Research and Development Expense
Since our inception, our operations have historically been focused primarily on organizing and staffing our company, raising capital, and acquiring, preparing for and advancing our product candidates into clinical development. Until recently, our research and development expenses included program-specific costs, as well as unallocated internal costs, such as the following:
Program-specific costs include:
•direct third-party costs, which include expenses incurred under agreements with CROs and contract manufacturing organizations, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research, manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, and any other third-party expenses directly attributable to the development of our prior product candidates; and
•payments for research and development milestones, which include costs incurred under our agreements with UMMS and Oxford.
Unallocated internal costs include:
•stock-based compensation expense for research and development personnel;
•personnel-related expenses, which include employee-related expenses, such as salaries, benefits and recruiting expenses, for research and development personnel; and
•other expenses, which include research and development software costs, travel expenses, laboratory facility rental costs and research and development equipment depreciation expenses, as well as the cost of consultants who assist with our research and development but are not allocated to a specific program.
Our research and development expenses are expected to decrease substantially in the near term as they are concentrated on one preclinical program.
General and Administrative Expense
General and administrative expenses consist primarily of employee-related
expenses such as salaries, benefits and travel expenses for our general and
administrative personnel; stock-based compensation, including stock-based
compensation allocated to us from our affiliate, Roivant Sciences Ltd. ("RSL"),
for certain RSL equity instruments granted to certain of our employees
(primarily our former CEO (the "RSL Equity Instruments"), who resigned as our
CEO in January 2022 ); non-employee benefit insurance premiums; third-party legal
and accounting fees; information technology costs; office rent, fixed asset
depreciation and other overhead costs; and consulting services.
During the fiscal year ending March 31, 2023 , we anticipate that our general and
administrative expenses will decrease compared to the fiscal year ended March
31, 2022 , primarily as a result of stock-based compensation expense associated
with the RSL Equity Instruments, for which expensing commenced upon the
liquidity event vesting condition being met upon the closing of RSL's business
combination with Montes Archimedes Acquisition Corp. ("MAAC") on September 30,
2021 and ended by March 31, 2022 .
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Results of Operations for the Three and Six-Months Ended
The following table summarizes our results of operations for the three and
six-months ended
Three Months Ended September 30, Six Months Ended September 30,
2022 2021 Change 2022 2021 Change
Operating expenses:
Research and development expenses
(includes stock-based compensation
(benefit) expense of $(8) and $489
for the three months ended
September 30, 2022 and 2021 and
$(409) and $921 for the six months
ended September 30, 2022 and 2021,
respectively) $ 336 $ 11,448 $ (11,112) $ 5,878 $ 19,506 $ (13,628)
General and administrative expenses (includes stock-based compensation expense of$223 and$6,809 for the three months endedSeptember 30, 2022 and 2021 and$465 and$7,698 for the six months ended September 30, 2022 and 2021, respectively) 2,941 9,748 (6,807) 5,933 13,607 (7,674) Total operating expenses 3,277 21,196 (17,919) 11,811 33,113 (21,302) Other expense, net (197) 41 (238) (321) 22 (343) Loss before income tax benefit (3,080) (21,237) 18,157 (11,490) (33,135) 21,645 Income tax benefit - - - (4) (28) 24 Net loss$ (3,080) $ (21,237) $ 18,157 $ (11,486) $ (33,107) $ 21,621
Research and Development Expenses
Our research and development expenses during the three and six-months ended
Three Months Ended September 30, Six Months Ended September 30,
2022 2021 Change 2022 2021 Change
Program-specific costs $ (1,198) $ 7,381 $ (8,579) $ 2,286 $ 11,357 $ (9,071)
Unallocated internal costs:
Personnel-related 134 2,163 (2,029) 1,676 4,663 (2,987)
Stock-based compensation expense (8) 489 (497) (409) 921 (1,330)
Other 1,408 1,415 (7) 2,325 2,565 (240)
Total research and development
expenses $ 336 $ 11,448 $ (11,112) $ 5,878 $ 19,506 $ (13,628)
Research and development expenses were $0.3 million for the three months ended
September 30, 2022 and $11.4 million for the three months ended September 30,
2021 . The $11.1 million decrease was primarily related to decreases in:
(i) program-specific costs relating to our prior AXO-Lenti-PD and AXO-AAV-GM1
and AXO-AAV-GM2 programs, which decreased $8.6 million as we wound down our
clinical-stage programs subsequent to our termination of the Oxford Agreement
and the UMMS Agreement; and
(ii) unallocated internal costs, which decreased $2.5 million primarily due to
reductions in personnel-related costs after announcing the discontinuation of
our clinical-stage programs and initiating a significant reduction in workforce
in April 2022 . Other costs incurred during the three months ended September 30,
2022 included $0.7 million related to the early termination of the laboratory
space lease in Durham, North Carolina and $0.6 million of losses on sales of
equipment and furniture related to the termination of that lease.
Program-specific costs were
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Research and development expenses were
(i) program-specific costs relating to our prior AXO-Lenti-PD and AXO-AAV-GM1 and AXO-AAV-GM2 programs, which decreased$9.1 million as we wound down our clinical-stage programs subsequent to our termination of the Oxford Agreement and the UMMS Agreement; and (ii) unallocated internal costs, which decreased$4.6 million primarily due to reductions in personnel-related costs after announcing the discontinuation of our clinical-stage programs and initiating a significant reduction in workforce inApril 2022 . Personnel-related costs incurred during the six months endedSeptember 30, 2022 included$0.7 million of severance expense. Other costs incurred during the six months endedSeptember 30, 2022 included$0.7 million related to the early termination of the laboratory space lease inDurham, North Carolina and$0.6 million of losses on sales of equipment and furniture related to the termination of that lease. Further, stock-based compensation expense incurred during the six months endedSeptember 30, 2022 benifited from the reversal of$0.4 million from prior periods resulting from the workforce reduction.
General and Administrative Expenses
General and administrative expenses were$2.9 million for the three months endedSeptember 30, 2022 and$9.7 million for the three months endedSeptember 30, 2021 . The decrease of$6.8 million was primarily due to decreases of$6.6 million in stock-based compensation expense,$5.9 million of which results from prior year expense associated with RSL equity instruments held by our former Chief Executive Officer, and$0.6 million in personnel-related expenses related to the workforce reduction that commenced inApril 2022 . General and administrative expenses were$5.9 million for the six months endedSeptember 30, 2022 and$13.6 million for the six months endedSeptember 30, 2021 . The decrease of$7.7 million was primarily due to a decrease of$7.2 million in stock-based compensation expense,$5.9 million of which results from prior year expense associated with RSL equity instruments held by our former Chief Executive Officer, and a decrease of$1.1 million in personnel-related expenses.
Other (Income) Expense, net
Other (income) expense, net was$(0.2) million and$41 thousand for the three months endedSeptember 30, 2022 and 2021, respectively. Other income, net for the three months endedSeptember 30, 2022 consisted primarily of$0.2 million of interest income. Other expense, net for the three months endedSeptember 30, 2021 consisted primarily of foreign exchange losses and interest expense, partially offset by interest income. Other (income) expense, net was$(0.3) million and$22 thousand for the six months endedSeptember 30, 2022 and 2021, respectively. Other income, net for the six months endedSeptember 30, 2022 consisted primarily of$0.3 million of interest income. Other expense, net for the six months endedSeptember 30, 2021 consisted primarily of foreign exchange losses and interest expense, partially offset by interest income.
Liquidity and Capital Resources
Sources of Liquidity
Since our initial public offering inJune 2015 , our operations have been financed primarily through sales of common stock and pre-funded warrants, as well as borrowings under our credit facilities. As ofSeptember 30, 2022 , we had$49.9 million of cash and cash equivalents available to us.
Capital Requirements
We have not yet achieved profitability and expect to continue to incur operating
and net losses, as well as negative cash flows from operations, for the
foreseeable future. We have not generated any revenue to date. Until such time,
if ever, as we can generate substantial product revenue, and subject to our
pursuit of strategic alternatives, we expect to primarily finance our cash needs
using our existing cash.
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For the six months ended September 30, 2022 and the fiscal year ended March 31,
2022 , we incurred net losses of $11.5 million and $71.9 million , respectively.
As of September 30, 2022 , our cash and cash equivalents totaled $49.9 million
and our accumulated deficit was $874.4 million . We expect that our existing cash
and cash equivalents of $49.9 million at September 30, 2022 will enable us to
fund our current operating plan beyond the twelve-month period following the
date that the accompanying unaudited condensed consolidated financial statements
and footnotes were issued. In order to meet longer operating requirements,
including as we continue to explore and pursue strategic alternatives, we will
need additional capital resources. We have based these estimates on assumptions
that may prove to be wrong, and we could use our available capital resources
sooner than we currently expect. Our principal operating focus is currently on
pursuing a range of strategic alternatives. We believe we have sufficient cash
resources, net of costs which we estimate to incur in relation to such a
transaction, to complete a strategic transaction. If we do not complete a
strategic transaction, we may consider dissolving the Company and liquidating
the assets. In that case, we believe that our cash resources are sufficient to
satisfy estimated liabilities and costs of such a process. However, the
achievement of a strategic transaction and the associated costs and timing
thereof is uncertain and the time, cost and reserves which may be required to be
held back for future claims is uncertain so our estimates may prove incorrect.
Our future funding requirements, both near and long-term, will depend on many
factors, including, but not limited to, the timing and outcome of our
exploration of, and execution upon any, potential strategic alternatives, the
cost of obtaining necessary intellectual property and defending potential
intellectual property disputes, realization of the anticipated benefits of our
headcount reduction, and the costs of operating as a public company.
We expect to primarily finance our cash needs using our existing cash. We do not
currently have any committed external source of funds. We continually assess
multiple options to obtain additional funding to support our operations,
including proceeds from offerings of our equity securities or debt financings.
To the extent that we raise additional capital through the sale of equity or
convertible debt securities, our stockholders' ownership interests will be
diluted, and the terms of these securities may include liquidation or other
preferences that adversely affect our stockholders' rights. Debt financing and
preferred equity financing, if available, may involve agreements that include
covenants limiting or restricting our ability to take specific actions, such as
incurring additional debt, making capital expenditures or declaring dividends.
Sources of a sufficient amount of financing may not be available to us on
favorable terms, if at all, and our ability to raise additional capital has
been, and may continue to be, adversely impacted by, among other things,
potentially worsening global economic conditions and the recent disruptions to
and volatility in the credit and financial markets in the United States and
worldwide resulting from the ongoing COVID-19 pandemic. In addition, extreme
price and volume fluctuations in the stock market in general, and the Nasdaq
Global Select Market, in particular, have resulted in volatile and sometimes
decreased stock prices for many companies, including us. Broad market and
industry factors, including worsening economic conditions and other adverse
effects or developments relating to the evolving effects of the COVID-19
pandemic, may negatively affect the market price of our common stock, regardless
of our actual operating performance, and impact our ability to raise sufficient
additional capital on acceptable terms, if at all.
At-the-Market Equity Offering Program
We have engagedSVB Securities LLC as our agent to sell shares of our common stock from time to time through an at-the-market equity offering program.SVB Securities LLC is entitled to compensation for its services in an amount equal to 3% of the gross proceeds of any of our shares of common stock sold. During the six months endedSeptember 30, 2022 , we did not sell any shares of common stock under this program. During the six months endedSeptember 30, 2021 , we sold approximately 0.2 million shares of our common stock for total proceeds of approximately$0.5 million , net of brokerage fees, under this program. As ofSeptember 30, 2022 , we sold a total of approximately$30.4 million shares of our common stock for aggregate proceeds of approximately$92.0 million , net of brokerage fees, under and since the inception of this program.
Cash Flows
The following table sets forth a summary of our cash flows for each of the periods shown (in thousands):
Six Months Ended
2022 2021
Net cash used in operating activities $ (13,764) $ (21,919)
Net cash (used in) provided by investing
activities (100) 4,149
Net cash provided by financing activities - 479
Operating Activities
Cash flows from operating activities consist of net loss adjusted for non-cash
items, including depreciation and stock-based compensation expenses, as well as
the effect of changes in working capital and other activities.
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For the six months ended September 30, 2022 , net cash used in operating
activities was $13.8 million and was primarily attributable to a net loss of
$11.5 million , which includes costs incurred for research and development
activities, including CRO fees, manufacturing, regulatory and other clinical
trial costs, as well as our general and administrative expenses, in addition to
net decreases in accrued expenses and accounts payable of $7.4 million , which
were partially offset by a net decrease in prepaid expenses and other current
assets of $2.9 million , a decrease in income tax receivable of $1.3 million and
the disposal of $0.9 million of fixed assets.
For the six months ended September 30, 2021 , net cash used in operating
activities was $21.9 million and was primarily attributable to a net loss of
$33.1 million , which includes costs incurred for research and development
activities, including CRO fees, manufacturing, regulatory and other clinical
trial costs, as well as our general and administrative expenses, in addition to
net decreases in accrued expenses and accounts payable of $0.5 million , which
were partially offset by $8.6 million of non-cash stock-based compensation
expense and a net decrease in prepaid expenses and other current assets of $3.0
million .
Investing Activities
Cash used in investing activities was $0.1 million for the six months ended
September 30, 2022 , consisting of $0.3 million of purchases of fixed assets,
partially offset by proceeds of $0.2 million from dispositions of fixed assets.
Net cash provided by investing activities was $4.1 million for the six months
ended September 30, 2021 , consisting primarily of $4.3 million of cash proceeds
from the sale of our long-term investment in Arvelle, partially offset by
purchases of fixed assets.
Financing Activities
For the six months endedSeptember 30, 2022 , net cash provided by financing activities was zero. For the six months endedSeptember 30, 2021 , net cash provided by financing activities was$0.5 million and consisted of net proceeds from the issuance and sale of our shares of common stock under our share sales agreement withSVB Securities LLC .
Contractual Obligations
As ofSeptember 30, 2022 , our real property lease obligations have been reduced to zero as a result of agreements reached during the six months endedSeptember 30, 2022 for the early termination of lease agreements for an office facility inNew York, New York and for a research and development facility and related office space inDurham, North Carolina .
Critical Accounting Policies and Significant Judgments and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance withU.S. generally accepted accounting principles ("GAAP"). The preparation of these unaudited condensed consolidated financial statements and accompanying notes requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance withU.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. Significant estimates include research and development accruals. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We define our critical accounting policies as those underU.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. Our significant accounting policies are more fully described in Note 2, "Summary of Significant Accounting Policies," to our unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q and in Note 2, "Summary of Significant Accounting Policies," to our audited consolidated financial statements in our Annual Report on Form 10-K. Not all of these significant accounting policies, however, require that we make estimates and assumptions that we believe are "critical accounting estimates." We believe that our estimates relating to research and development accruals have the greatest potential impact on our consolidated financial statements and consider these to be our critical accounting policies and estimates and are "critical accounting estimates." There have been no material changes to our critical accounting policies and significant judgments and estimates as compared to the critical accounting policies and significant judgments and estimates described in our Annual Report. 23
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Recent Accounting Pronouncements
For a discussion of recent accounting pronouncements, see "Note 2(F)-Recent Accounting Pronouncements" in the accompanying notes to the unaudited condensed consolidated financial statements included in "Item 1-Financial Statements" of this Quarterly Report on Form 10-Q for additional information.
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